Spinal Cord Stimulation for Parkinson's Disease

(SCS for FOG Trial)

Recruiting at 1 trial location

Overseen By Rory Mahabir

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nora Vanegas-Arroyave

Must be taking: Dopaminergic medications

Must not be taking: Anticoagulants

Disqualifiers: Psychosis, Depression, Anxiety, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 12 months

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Parkinson Disease (PD) patients experience a variety of motor issues such as walking difficulties, loss of balance, and freezing while walking, which impacts their quality of life. Some symptoms, like freezing of gait (FOG), do not respond to medications typically used to treat PD. Current surgical procedures used to alleviate PD symptoms also do not always improve FOG. Since many traditional therapies have failed for the treatment of FOG, researchers have proposed the use of newer treatments. Recent research in animal models and clinical human data using SCS has produced promising results, specifically showing improvement in FOG with the use of SCS in patients with PD. The purpose of this study is to evaluate the effectiveness of spinal cord stimulation (SCS) for the management of freezing of gait (FOG) that does not respond to conventional treatments in subjects with Parkinson's disease (PD). The investigators hypothesize that SCS significantly decreases FOG episodes in patients with PD. 1. Assess the safety, tolerability and preliminary evidence of effectiveness of upper thoracic spinal cord stimulation for freezing of gait in Parkinson's (PD) patients. 2. Explore the effects of two SCS programming paradigms on motor, nonmotor and quality of life measures in PD patients with freezing of gait.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that patients on anticoagulation treatment must stop these medications 7 days before the procedure. It seems you can continue other Parkinson's treatments like dopaminergic medications or deep brain stimulation.

Is spinal cord stimulation generally safe for humans?

Spinal cord stimulation (SCS), including the high-frequency 10 kHz (HF10) therapy, is generally considered safe, with safety profiles similar to traditional SCS. Common issues are related to surgical site infection and hardware malfunction, but rare neurological effects like tinnitus and vertigo have been reported, which resolved after deactivating the device. ^{1 2 3 4 5}

How is the Spinal Cord Stimulation treatment different from other treatments for Parkinson's Disease?

The Spinal Cord Stimulation (SCS) treatment, specifically the Nevro HF10 system, is unique because it uses high-frequency 10 kHz stimulation to manage symptoms without causing paresthesia (tingling sensation), unlike traditional low-frequency SCS. This treatment is also notable for not requiring intraoperative paresthesia mapping, which simplifies the procedure and reduces operating room time. ^{1 2 5 6 7}

What data supports the effectiveness of the treatment Spinal Cord Stimulation for Parkinson's Disease?

Research shows that the HF10 spinal cord stimulation therapy, used in the Senza System, is effective in providing long-term pain relief for back and leg pain without causing tingling sensations. This suggests potential benefits for managing pain in Parkinson's Disease, although direct evidence for Parkinson's is still being explored. ^{1 2 3 5 7}

Who Is on the Research Team?

Nora Vanegas, MD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Parkinson's Disease who have optimized their treatment but still experience at least two episodes of freezing gait daily that don't improve with medication. They must meet specific criteria for PD diagnosis and be able to consent. Excluded are those with certain psychiatric illnesses, uncontrolled medical conditions, or on anticoagulants they can't stop before the procedure.

Inclusion Criteria

I experienced freezing while moving, even after taking my regular Levodopa dose.

Documented dopaminergic response

I am receiving the best possible treatment for Parkinson's, including medications or DBS.

Exclusion Criteria

I do not have severe mental health issues that could affect my study participation.

I am on blood thinners and cannot stop them for 7 days before a procedure.

I have severe, ongoing pain in my back or leg after surgery, or I have CRPS.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo spinal cord stimulation (SCS) with either burst or tonic stimulation to assess effects on freezing of gait (FOG) in Parkinson's Disease

12 months

Regular visits for SCS programming and monitoring

Follow-up

Participants are monitored for safety, tolerability, and effectiveness of SCS on FOG, including assessments using PDQ-39, NMSS, NFOG-Q, and other measures

12 months

Periodic assessments over 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Spinal Cord Stimulator (SCS)

Trial Overview The study tests if spinal cord stimulation (SCS) can reduce episodes of freezing gait in Parkinson's patients when standard treatments fail. It will compare two SCS programming methods to see how they affect motor skills, nonmotor symptoms, and life quality.

How Is the Trial Designed?

Group I: Spinal Cord Stimulation (SCS) Tonic stimulation Experimental Treatment 1 Intervention

Tonic stimulation

Group II: Spinal Cord Stimulation (SCS) Burst stimulation Experimental Treatment 1 Intervention

Burst stimulation.

Spinal Cord Stimulator (SCS) is already approved in United States, European Union for the following indications:

Approved in United States as Nevro HF10 Spinal Cord Stimulation Therapy for:

• Chronic intractable pain of the trunk and/or limbs
• Failed back surgery syndrome
• Intractable low back pain
• Leg pain
• Painful diabetic neuropathy

Approved in European Union as Nevro HF10 Spinal Cord Stimulation Therapy for:

• Chronic intractable pain of the trunk and/or limbs
• Failed back surgery syndrome
• Intractable low back pain
• Leg pain
• Painful diabetic neuropathy

Who Is Running the Clinical Trial?

Nora Vanegas-Arroyave

Lead Sponsor

Trials

1

Recruited

10+

Nora Vanegas

Lead Sponsor

Trials

2

Recruited

20+

Published Research Related to This Trial

The HF10 spinal cord stimulator (SCS) is as effective as traditional low-frequency SCS for treating back and leg pain, with some studies indicating it may provide superior long-term relief.

The HF10 SCS system has a comparable safety profile to traditional SCS and simplifies the implantation process by eliminating the need for intraoperative paresthesia mapping, enhancing patient experience and reducing surgery time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the Senza System: a novel, high frequency 10 kHz (HF10), paresthesia free spinal cord stimulator. Ghosh, PE., Simopolous, TT.[2020]

Spinal cord stimulation (SCS) showed a significant reduction in motor symptoms for Parkinson's disease patients, with an average decrease of 4.43 points on the Unified Parkinson Disease Rating Scale-III (UPDRS-III), indicating a 14% improvement.

SCS also effectively reduced pain, with a 59% decrease in Visual Analogue Scale (VAS) scores for back and leg pain, suggesting it may provide substantial pain relief in addition to motor benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal Cord Stimulation for Parkinson's Disease: A Systematic Review and Meta-Analysis of Pain and Motor Outcomes. Sarica, C., Zemmar, A., Yousefi, O., et al.[2023]

Spinal cord stimulation (SCS) significantly reduced pain in Parkinson's Disease patients, with an average reduction of 59% in Visual Analogue Scale (VAS) scores across 15 participants, and up to 67% for those using cycling burst stimulation.

SCS also improved motor symptoms, with 73% of patients showing better performance in a 10-meter walking test and 64% experiencing clinically relevant improvements in the Timed Up and Go (TUG) test, indicating its potential as a treatment option for both pain and motor issues in Parkinson's Disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single arm prospective multicenter case series on the use of burst stimulation to improve pain and motor symptoms in Parkinson's disease. Chakravarthy, KV., Chaturvedi, R., Agari, T., et al.[2022]

HF10 spinal cord stimulation (SCS) therapy provides effective pain relief for chronic back and leg pain without causing paresthesia, making it a unique option for patients.

Clinical trials and reports indicate that HF10 SCS is safe and effective, even for patients who have not found relief with other neuromodulation therapies, suggesting it could be an important early treatment for chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

10-kHz High-Frequency SCS Therapy: A Clinical Summary. Russo, M., Van Buyten, JP.[2022]

In a study of 256 patients with chronic intractable pain, 73% reported successful trials with high frequency spinal cord stimulation (HF10 therapy), particularly those with back and leg pain, showing its effectiveness as a treatment option.

Patients experienced a sustained mean pain reduction of 50% up to 6 months post-implant, with significant improvements in functional outcomes, making HF10 a promising alternative to traditional spinal cord stimulation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High Frequency Spinal Cord Stimulation at 10 kHz for the Treatment of Chronic Pain: 6-Month Australian Clinical Experience. Russo, M., Verrills, P., Mitchell, B., et al.[2019]

A patient experienced neurological complications, including tinnitus, vertigo, and facial twitches, after receiving a high-frequency spinal cord stimulator, which resolved upon deactivation of the device.

This case highlights the need for further research into the less common neurological side effects of spinal cord stimulation therapy, as current knowledge primarily focuses on surgical site infections and hardware issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Onset Tinnitus after High-Frequency Spinal Cord Stimulator Implantation. Golovlev, AV., Hillegass, MG.[2020]

Spinal cord stimulation (SCS) is a safe and effective surgical treatment for chronic neuropathic pain, particularly beneficial for patients with Parkinson's disease.

Tonic SCS has been shown to improve gait disorders, motor symptoms, and overall quality of life in Parkinson's patients, even those who do not respond to dopamine treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tonic spinal cord stimulation as therapeutic option in Parkinson disease with axial symptoms: Effects on walking and quality of life. Hubsch, C., D'Hardemare, V., Ben Maacha, M., et al.[2020]

Citations

1. England pubmed.ncbi.nlm.nih.gov

A review of the Senza System: a novel, high frequency 10 kHz (HF10), paresthesia free spinal cord stimulator. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Spinal Cord Stimulation for Parkinson's Disease: A Systematic Review and Meta-Analysis of Pain and Motor Outcomes. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Single arm prospective multicenter case series on the use of burst stimulation to improve pain and motor symptoms in Parkinson's disease. [2022]

4. England pubmed.ncbi.nlm.nih.gov

10-kHz High-Frequency SCS Therapy: A Clinical Summary. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

High Frequency Spinal Cord Stimulation at 10 kHz for the Treatment of Chronic Pain: 6-Month Australian Clinical Experience. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

New Onset Tinnitus after High-Frequency Spinal Cord Stimulator Implantation. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Tonic spinal cord stimulation as therapeutic option in Parkinson disease with axial symptoms: Effects on walking and quality of life. [2020]